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临床试验/NCT02605499
NCT02605499已完成不适用

Ultra Violet-C Light Evaluation as an Adjunct to Removing Multi-Drug Resistant Organisms (UVCLEAR-MDRO)

Johns Hopkins University0 个研究点目标入组 83 人开始时间: 2015年12月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
83
主要终点
Acquisition of Vancomycin Resistant Enterococcus

研究概览

简要总结

This study examines the impact of UV-C light disinfection as an adjunct to routine daily and discharge patient room cleaning on patient infection and colonization with hospital associated bacteria.

Patient rooms are counted as enrolled since consent was waived and the number of participants is unknown. Total of 83 rooms.

详细描述

Effective cleaning of the patient environment (the patient room during hospital stay) is subject to human factors and unfortunately is often inconsistent or inadequate. Patient rooms that have residual bacteria after routine environmental cleaning can act as reservoirs for multidrug-resistant organisms (MDROs) and contribute to the spread of MDROs from patient to patient. In the setting of an increased focus on Healthcare-associated Infections such as Clostridium difficile (C. difficile) and multidrug-resistant Gram negative and Gram positive organisms such as carbapenem-resistant Enterobacteriaceae (CRE), vancomycin-resistant Enterococcus (VRE) and methicillin-resistant Staphlococcus aureus (MRSA), Ultra-Violet C (UV-C) light has been shown to be a safe, effective way to decrease the burden of MDROs in patient rooms. However, studies examining the effectiveness of UV-C light when used post daily and discharge patient room cleaning are lacking.

This study is a cluster, randomized, two-period cross over trial to investigate the relationship between environmental decontamination with UV-C light and transmission of VRE and other healthcare-associated bacteria. It investigates the hypothesis that UV-C in addition to daily cleaning leads to decreased patient acquisition of healthcare-associated bacteria.

This study is important to further advance hospital-based infection prevention knowledge of the impact of UV-C light for environmental cleaning.

Patient rooms are counted as enrolled since consent was waived and the number of participants is unknown. Total of 83 rooms.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
None

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient rooms in pre-selected hospital units within Johns Hopkins Hospital

排除标准

  • None, intervention is at level of the hospital unit, not the patient

研究组 & 干预措施

UV-C light disinfection

Experimental

During intervention UV-C light disinfection will be used in hospital patient rooms as an adjunct to routine daily and discharge cleaning.

干预措施: UV-C light disinfection (Other)

Control

No Intervention

During control period there will be standard discharge and daily room cleaning only, with no UV-C light disinfection.

结局指标

主要结局

Acquisition of Vancomycin Resistant Enterococcus

时间窗: 2 years

Rates of Vancomycin Resistant Enterococcus acquisition will be compared between intervention and control periods.

Acquisition of a composite rate of healthcare-associated bacteria: Vancomycin Resistant Enterococcus, Methicillin Resistant Staphylococcus Aureus, hospital-onset bacteremias, Clostridium difficile, and central line associated bloodstream infections.

时间窗: 2 years

Rates of Vancomycin Resistant Enterococcus, Methicillin Resistant Staphylococcus Aureus, hospital-onset bacteremias, multidrug resistant gram negative bacteria, Clostridium difficile, and central line associated bloodstream infections will be compared between intervention and control periods.

次要结局

  • Acquisition of Vancomycin Resistant Enterococcus (colonization)(2 years)
  • Acquisition of Methicillin Resistant Staphylococcus Aureus (colonization)(2 years)
  • Acquisition of Vancomycin Resistant Enterococcus (clinical infection)(2 years)
  • Acquisition of Clostridium difficile (infection)(2 years)
  • Acquisition of Methicillin Resistant Staphylococcus Aureus (clinical)(2 years)
  • Differences in patient overall satisfaction with hospital stay as assessed by the Hospital Consumer Assessment of Healthcare Providers and Systems Survey.(2 years)
  • Acquisition of Clostridium difficile (colonization or infection)(2 years)
  • Acquisition of multidrug resistant gram negative bacteria (colonization)(2 years)
  • Acquisition of multidrug resistant gram negative bacteria(2 years)
  • Acquisition of bacteremia(2 years)
  • Acquisition of Methicillin Resistant Staphylococcus Aureus (clinical or colonization)(2 years)
  • Acquisition of Central line associated bloodstream infections(2 years)
  • Differences in patient satisfaction with environmental cleaning as assessed by the Hospital Consumer Assessment of Healthcare Providers and Systems Survey.(2 years)

研究者

申办方类型
Other
责任方
Sponsor

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